Long-term Study to Assess the Safety and Effectiveness of NMRA-335140 in Participants With Major Depressive Disorder
Neumora Therapeutics, Inc.
Summary
This is a 52-week open-label extension (OLE) study that will evaluate the safety, tolerability, and effectiveness of NMRA-335140 in participants with major depressive disorder (MDD). Participants who completed a parent study investigating the efficacy and safety of NMRA-335140 as a treatment for MDD (ie, NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303), and complete the 6 weeks double-blind treatment, provide informed consent, and meet eligibility criteria, may enter this extension study.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: Rollover participants are eligible for the study if the following inclusion criteria are met: * Completed a previous NMRA-335140 Phase 3 MDD study (example: NMRA-335140-301, NMRA-335140-302, or NMRA-335140-303) according to the completion definition in the parent study protocol. * Signed an informed consent form (ICF) for this study. * Willing to comply with the contraception requirements described in the inclusion criteria of the parent study protocol. * Willing to comply with the concomitant medication/therapy restrictions described in the exclusion criteria of the…
Interventions
- DrugNMRA-335140
Participants will receive NMRA-335140 at a dose of 80 mg once daily (QD), orally during a 52-week treatment period.
Locations (178)
- Neumora Investigator siteHuntsville, Alabama
- Neumora Investigator SitePhoenix, Arizona
- Neumora Investigator SiteBentonville, Arkansas
- Neumora Investigator Site #1Little Rock, Arkansas
- Neumora Investigator siteLittle Rock, Arkansas
- Neumora Investigator SiteRogers, Arkansas